Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule hereto:

Schedule

Provisional consent is granted for two years from 29 April 2022.

This consent is given subject to the following conditions:

This vaccine may only be sold to the New Zealand Government and distributed in accordance with the New Zealand Government’s COVID-19 vaccine rollout or donated to other countries.

The New Zealand Sponsor must fulfil the following obligations within the timelines specified, the dates of which may be altered by mutual agreement with Medsafe:

1. The New Zealand site of batch release will only release batches for distribution in New Zealand once the sponsor has verified that the shipping temperature profile meets specifications.
2. Provide additional drug substance stability data and analysis to confirm the storage period at -90°C to -55°C, 2°C to 8°C, and 23°C to 27°C/55-65% RH storage conditions (for Process 3 and 4), for the pre-PPQ lots and three PPQ lots manufactured at each drug substance commercial site within five working days of submission to the EMA.
3. Provide additional finished product stability data to confirm the storage period with Process 4 batches from both the EU and the Amylin Ohio, US drug product manufacturing sites within five working days of submission to the EMA.
4. Report the recalculation of the average loss of infectivity rate during finished product storage at 2 to 8°C based on commercial process stability data within five working days of submission to the EMA. If needed the release specification should be changed in order to ensure that batches will remain within shelf life specification during storage and handling via submission of a Changed Medicine Notification.
5. Provide further efficacy and safety data from studies COV001, COV002, COV003 and COV005 including the final pooled analysis and Final Clinical Study reports within five working days of these being produced.
6. Provide any reports on the requirement for and timing of booster doses within five working days of these being produced.
7. Provide the Final Clinical Study report overview and summaries of Study D8110C0001 within five working days of these being produced.
8. Provide Periodic Safety Update Reports according to the same schedule as required by the EMA.
9. Provide monthly safety reports according to the same schedule as required by the EMA, as well as all safety reviews they conduct or become aware of.
10. Perform the required pharmacovigilance activities and interventions detailed in the agreed RMP and any agreed updates to the RMP. An RMP should be submitted at the request of Medsafe or whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important milestone being reached.

Dated this 27th day of April 2022.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).